Tolerance Assessment of Tailored 3d-printed Transparent Face Orthosis With Silicone Interface for the Treatment of Post-burn Face Scar
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 13
- 主要终点
- Number of Local Side Effects
研究概览
简要总结
The purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.
详细描述
Burn injuries are not a rare affection. According to WHO (World Health Organization), in 2004 there were 11 million peoples in the world who were affected by burn injuries caused by fire and who needed medical cares. This important number ignores non-fire thermal, chemical and electrical burns. Face is one of the most susceptible areas of burn where the prevalence was reported to be 6-60%.
Hypertrophic scars (HS) are frequent consequences of dermal burn with a prevalence of 70% of burned people. HS, which are a dermal fibro-proliferation, are rigid, erythematous and thickened scars associated with pigmentation abnormalities, xerosis, thermal sensitivity, pain and pruritus.
When HS is located on the face, they can cause cosmetic disorder with disfigurement and psychological distress.
Pressure therapy and silicone application are the two recommended non-invasive care for prevention and treatment of hypertrophic scarring after burn. On the face, Pressure Garment Therapy (PGT) cannot exert the required pressure because of concave or flat shape so the use of face mask is the most common form of pressure therapy on the face.
The face mask manufacturing is artisanal, time consuming and variable between all burn centers. They are not very accurate and have difficulties to apply effective pressure on certain face areas such as nasolabial folds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Post-Burn Face scar during maturation stage or surgical intervention on post-burn face scar during maturation stage
- •Patient agrees to shave beard if necessary for 3D camera measurement
- •Patient able to express informed consent
- •Affiliation to a social security scheme
排除标准
- •Post burn face scar in the sequela stage
- •Patient with unbalanced photosensitive epilepsy
- •Patient with an unconsolidated fracture of the face's bones or skull
- •Patient with a known allergy to silicone
- •Pregnant or lactating women
结局指标
主要结局
Number of Local Side Effects
时间窗: Month 1
wound, device related pain, rash, temporomandibular joint pain, dental pain, suffocating sensation
次要结局
- Reprints(Month 1; Month 6; Month 12; Month18; Month 24)
- Number of Local side effects(Month 6)
- Evaluation of scar evolution with POSAS(Month 1; Month 6; Month 12; Month 18; Month 24)
- Manufacturing time(Month 1; Month 6; Month 12; Month 18; Month 24)
- Device lifetime(Month 1; Month 6; Month 12; Month18; Month 24)
- Evaluation of the quality of life with the BSHS-B(Month 1; Month 6; Month 12; Month 18; Month 24)
- Evaluation of scar evolution with VSS(Month 1; Month 6; Month 12; Month 18; Month 24)
- Wearing time(Month 1; Month 6; Month 12; Month 18; Month 24)
